Nocturnal EnuresisPhase 3NCT02538302
Minirin Versus Oxybutynin for Nocturnal Enuresis in Children
A Phase 3 study testing Minirin and Oxybutynin in people with Nocturnal Enuresis, run by Hormozgan University of Medical Sciences at 1 site in Iran.
Trial summary
Nocturnal enuresis is among the most common disorders in children. The aim of current study was to compare the efficacy and safety of Minirin and oxybutynin for treatment of nocturnal enuresis in children in Bandar Abbas in 2014. Read more about this study
- Who is it for?
- Ages 5 to 14 years
- Conditions the study is for
- Nocturnal Enuresis
- What is being tested?
- Minirin and Oxybutynin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteIran
- Study dates
- Jul 2013to Aug 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- >5 years old
- Nocturnal enuresis
- Candidate for pharmacological treatment
Who cannot join
- Children who their parents did noted filled the informed consent form
- Impossibility of follow up during the study period
- History of seizure
- History of rheumatologic disorders such as sjogren's disease
Trial locations and contacts
1 site in 1 country.
About this study
Nocturnal enuresis is among the most common disorders in children. The aim of current study was to compare the efficacy and safety of Minirin and oxybutynin for treatment of nocturnal enuresis in children in Bandar Abbas in 2014.
Read the detailed description
Nocturnal enuresis is among the most common disorders in children. Several pharmacological and non-pharmacological treatments are available for nocturnal enuresis. Studies for reaching the best pharmacological treatment for this disorder are continuing. The aim of current study was to compare the efficacy and safety of Minirin and oxybutynin for treatment of nocturnal enuresis in children in Bandar Abbas in 2014.
- Conditions
- Nocturnal Enuresis
- Being tested
- Minirin, Oxybutynin
- Keywords
- Minirin, Oxybutynin, Nocturnal enuresis
- Medical subject headings
- Nocturnal Enuresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MinirinDrug
Also called Desmopressin acetate
Minirin 5 to 10 mg daily for 6 months
OxybutyninDrug
Also called Ditropan
Oxybutynin 5 to 10 mg daily for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Minirin | Experimental | 120 microgram per day for 2 months, then 60 microgram per day for 2 months, then 60 microgram every two days for two months Receives: Drug: Minirin |
| Oxybutynin | Active comparator | 5 mg Oxybutynin twice a daily for 6 months Receives: Drug: Oxybutynin |
What is being measured
The primary outcome is the main question the study is designed to answer.
ّFrequency of nocturnal enuresis
Number of participants with nocturnal enuresis
Measured: 6 months
Secondary outcomes (17)
Frequency of urinary incontinency
Number of participants with urinary incontinency
Measured: 6 months
Frequency of urgency
Number of participants with urgency
Measured: 6 months
Frequency of Xerostomia
Number of participants with Xerostomia
Measured: 6 months
Frequency of Xerophthalmia
Number of participants with Xerophthalmia
Measured: 6 months
Frequency of Blurred vision
Number of participants with Blurred vision
Measured: 6 months
Frequency of Dysphagia
Number of participants with Dysphagia
Measured: 6 months
Frequency of constipation
Number of participants with constipation
Measured: 6 months
Frequency of Diarrhea
Number of participants with Diarrhea
Measured: 6 months
Frequency of Headache
Number of participants with Headache
Measured: 6 months
Frequency of Seizure
Number of participants with Seizure
Measured: 6 months
Frequency of Epistaxis
Number of participants with Epistaxis
Measured: 6 months
Frequency of Abdominal pain
Number of participants with Abdominal pain
Measured: 6 months
Frequency of Vomiting
Number of participants with Vomiting
Measured: 6 months
Frequency of Ear ache
Number of participants with Ear ache
Measured: 6 months
Frequency of Rhinitis
Number of participants with Rhinitis
Measured: 6 months
Frequency of Chest pain
Number of participants with Chest pain
Measured: 6 months
Frequency of Increase in appetite
Number of participants with Increase in appetite
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2015 (estimated)
- Study startJul 2013
- Primary completionJul 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nocturnal EnuresisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hormozgan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamidreza Mahboobi, Hormozgan University of Medical Sciences
- Investigators
- Hamidreza Mahboobi, M.D, Principal investigator, Hormozgan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02538302
- Sponsor's protocol ID
- 92.121.505
- Status last verified
- Aug 2015
- First submitted
- 27 Aug 2015
- Last updated
- 2 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ghasemi K, Esteghamati M, Mohammadzadeh M, Zare S. Desmopressin versus Oxybutynin for Nocturnal Enuresis in Children in Bandar Abbas: A Randomized Clinical Trial. Electron Physician. 2016 Mar 25;8(3):2187-93. doi: 10.19082/2187. eCollection 2016 Mar.
PubMed 27123229
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minirin Versus Oxybutynin for Nocturnal Enuresis in Children
- ClinicalTrials.gov ID
- NCT02538302
- Acronym / sponsor ID
- 92.121.505
- Conditions
- Nocturnal Enuresis
- Keywords
- Minirin, Oxybutynin, Nocturnal enuresis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Hormozgan University of Medical SciencesUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 2 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nocturnal enuresis is among the most common disorders in children. The aim of current study was to compare the efficacy and safety of Minirin and oxybutynin for treatment of nocturnal enuresis in children in Bandar Abbas in 2014.
Detailed description
Nocturnal enuresis is among the most common disorders in children. Several pharmacological and non-pharmacological treatments are available for nocturnal enuresis. Studies for reaching the best pharmacological treatment for this disorder are continuing. The aim of current study was to compare the efficacy and safety of Minirin and oxybutynin for treatment of nocturnal enuresis in children in Bandar Abbas in 2014.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minirin | Experimental | Drug: Minirin120 microgram per day for 2 months, then 60 microgram per day for 2 months, then 60 microgram every two days for two months |
| Oxybutynin | Active comparator | Drug: Oxybutynin5 mg Oxybutynin twice a daily for 6 months |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- >5 years old
- Nocturnal enuresis
- Candidate for pharmacological treatment
Key exclusion criteria (4 listed)
- Children who their parents did noted filled the informed consent form
- Impossibility of follow up during the study period
- History of seizure
- History of rheumatologic disorders such as sjogren's disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MinirinAlso: Desmopressin acetateMinirin 5 to 10 mg daily for 6 months | Drug | Minirin |
| OxybutyninAlso: DitropanOxybutynin 5 to 10 mg daily for 6 months | Drug | Oxybutynin |
Primary outcome
ّFrequency of nocturnal enuresis
Time frame: 6 months
Number of participants with nocturnal enuresis
17 secondary outcomes
Frequency of urinary incontinency
Time frame: 6 months
Frequency of urgency
Time frame: 6 months
Frequency of Xerostomia
Time frame: 6 months
Frequency of Xerophthalmia
Time frame: 6 months
Frequency of Blurred vision
Time frame: 6 months
Frequency of Dysphagia
Time frame: 6 months
Frequency of constipation
Time frame: 6 months
Frequency of Diarrhea
Time frame: 6 months
Frequency of Headache
Time frame: 6 months
Frequency of Seizure
Time frame: 6 months
Frequency of Epistaxis
Time frame: 6 months
Frequency of Abdominal pain
Time frame: 6 months
Frequency of Vomiting
Time frame: 6 months
Frequency of Ear ache
Time frame: 6 months
Frequency of Rhinitis
Time frame: 6 months
Frequency of Chest pain
Time frame: 6 months
Frequency of Increase in appetite
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2015.
- Derived from this study: PubMed 27123229Ghasemi K, Esteghamati M, Mohammadzadeh M, Zare S. Desmopressin versus Oxybutynin for Nocturnal Enuresis in Children in Bandar Abbas: A Randomized Clinical Trial. Electron Physician. 2016 Mar 25;8(3):2187-93. doi: 10.19082/2187. eCollection 2016 Mar.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hamidreza Mahboobi, M.D principal investigator
Hormozgan University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Minirin and Oxybutynin in people with Nocturnal Enuresis, run by Hormozgan University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ّFrequency of nocturnal enuresis (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02538302, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2015.